Mental DisordersQDSPsyCATNCT02491866
Computerized Adaptative Testing of Self-perceived Quality of Care in Psychiatry
A study testing to develop and validate a Computerized Adaptative Testing in people with Mental Disorders, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Objectives 1. to develop and validate a Computerized Adaptative Testing (CAT) of self-perceived quality of care in Psychiatry. 2. to analyze the implementation of this new measure in clinical practice : qualitative analysis of the relationship patient/professional. Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Mental Disorders
- What is being tested?
- to develop and validate a Computerized Adaptative Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 1 siteFrance
- Study dates
- 27 May 2015to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosis of schizophrenia, bipolar disorder or depression according DSM V
- criteria
- age over 18 years
- informed consent to participate
- French as the native language
Who cannot join
- diagnosis other than schizophrenia, bipolar disorder or depression according DSM V criteria
- decompensated organic disease, and mental retardation
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital de la conception Assistance Publique Hôpitaux de Marseille
Marseille, 13354
Laurent BOYER, 04 91 38 75 83, laurent.boyer@ap-hm.fr
About this study
Official title: Development and Implementation of a Computerized Adaptative Testing (CAT) of Self-perceived Quality of Care in Psychiatry
Objectives
- to develop and validate a Computerized Adaptative Testing (CAT) of self-perceived quality of care in Psychiatry.
- to analyze the implementation of this new measure in clinical practice : qualitative analysis of the relationship patient/professional.
Read the detailed description
Prospective and multicentric study
- Development and validation of the CAT. 4 steps :
- Elaboration of a pool of items, based on literature review and interview with patients.
- Selection of the most relevant items based on a qualitative approach using cognitive interview with patients.
- Calibration of the item bank : the psychometric properties of the item bank will be based on classical test and item response theories and approaches, including the evaluation of unidimensionality, item response theory model fitting, and analyses of differential item functioning.
- Metrological validation of the CAT.
- Analysis of the implementation of the CAT in clinical practice using interview with professionals and patients.
- Conditions
- Mental Disorders
- Being tested
- to develop and validate a Computerized Adaptative Testing
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
to develop and validate a Computerized Adaptative TestingOther
- Elaboration of a pool of items, based on literature review and interview with patients.
- Selection of the most relevant items based on a qualitative approach using cognitive interview with patients.
- Calibration of the item bank : the psychometric properties of the item bank will be based on classical test and item response theories and approaches, including the evaluation of unidimensionality, item response theory model fitting, and analyses of differential item functioning.
- Metrological validation of the CAT.
- Analysis of the implementation of the CAT in clinical practice using interview with professionals and patients.
| Study group | Role | What they receive |
|---|---|---|
| psychiatric patients | Other | patients with schizophrenia, bipolar disorder or depression according DSM V criteria Receives: Other: to develop and validate a Computerized Adaptative Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of care
computerized Adaptative Testing
Measured: 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study start27 May 2015
- Primary completionAug 2017
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491866
- Sponsor's protocol ID
- 2014-22
- Acronym
- QDSPsyCAT
- Status last verified
- Aug 2017
- First submitted
- 24 Jun 2015
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Fernandes S, Brousse Y, Zendjidjian X, Cano D, Riedberger J, Llorca PM, Samalin L, Dassa D, Trichard C, Laprevote V, Sauvaget A, Abbar M, Misdrahi D, Berna F, Lancon C, Coulon N, El-Hage W, Rozier PE, Benoit M, Giordana B, Caqueo-Urizar A, Yon DK, Tran B, Auquier P, Fond G, Boyer L. Psychometric Assessment of an Item Bank for Adaptive Testing on Patient-Reported Experience of Care Environment for Severe Mental Illness: Validation Study. JMIR Ment Health. 2024 May 16;11:e49916. doi: 10.2196/49916.
PubMed 38753416Boyer L, Fernandes S, Brousse Y, Zendjidjian X, Cano D, Riedberger J, Llorca PM, Samalin L, Dassa D, Trichard C, Laprevote V, Sauvaget A, Abbar M, Misdrahi D, Berna F, Lancon C, Coulon N, El-Hage W, Rozier PE, Benoit M, Giordana B, Caqueo-Urizar A, Yon DK, Tran B, Auquier P, Fond G. Development of the PREMIUM computerized adaptive testing for measuring the access and care coordination for patients with severe mental illness. Psychiatry Res. 2023 Oct;328:115444. doi: 10.1016/j.psychres.2023.115444. Epub 2023 Sep 1.
PubMed 37677894Fernandes S, Fond G, Zendjidjian X, Michel P, Lancon C, Berna F, Schurhoff F, Aouizerate B, Henry C, Etain B, Samalin L, Leboyer M, Misdrahi D, Llorca PM, Coldefy M, Auquier P, Baumstarck K, Boyer L. A conceptual framework to develop a patient-reported experience measure of the quality of mental health care: a qualitative study of the PREMIUM project in France. J Mark Access Health Policy. 2021 Feb 23;9(1):1885789. doi: 10.1080/20016689.2021.1885789.
PubMed 33680364Fernandes S, Fond G, Zendjidjian XY, Baumstarck K, Lancon C, Berna F, Schurhoff F, Aouizerate B, Henry C, Etain B, Samalin L, Leboyer M, Llorca PM, Coldefy M, Auquier P, Boyer L; French PREMIUM Group. Measuring the Patient Experience of Mental Health Care: A Systematic and Critical Review of Patient-Reported Experience Measures. Patient Prefer Adherence. 2020 Nov 3;14:2147-2161. doi: 10.2147/PPA.S255264. eCollection 2020.
PubMed 33192054Fernandes S, Fond G, Zendjidjian X, Michel P, Baumstarck K, Lancon C, Berna F, Schurhoff F, Aouizerate B, Henry C, Etain B, Samalin L, Leboyer M, Llorca PM, Coldefy M, Auquier P, Boyer L. The Patient-Reported Experience Measure for Improving qUality of care in Mental health (PREMIUM) project in France: study protocol for the development and implementation strategy. Patient Prefer Adherence. 2019 Jan 21;13:165-177. doi: 10.2147/PPA.S172100. eCollection 2019.
PubMed 30718945
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Implementation of a Computerized Adaptative Testing (CAT) of Self-perceived Quality of Care in Psychiatry
- ClinicalTrials.gov ID
- NCT02491866
- Acronym / sponsor ID
- QDSPsyCAT / 2014-22
- Conditions
- Mental Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 27 May 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Oct 2018 (estimated)
- First posted
- 8 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives
- to develop and validate a Computerized Adaptative Testing (CAT) of self-perceived quality of care in Psychiatry.
- to analyze the implementation of this new measure in clinical practice : qualitative analysis of the relationship patient/professional.
Detailed description
Prospective and multicentric study
- Development and validation of the CAT. 4 steps :
- Elaboration of a pool of items, based on literature review and interview with patients.
- Selection of the most relevant items based on a qualitative approach using cognitive interview with patients.
- Calibration of the item bank : the psychometric properties of the item bank will be based on classical test and item response theories and approaches, including the evaluation of unidimensionality, item response theory model fitting, and analyses of differential item functioning.
- Metrological validation of the CAT.
- Analysis of the implementation of the CAT in clinical practice using interview with professionals and patients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| psychiatric patients | Other | Other: to develop and validate a Computerized Adaptative Testingpatients with schizophrenia, bipolar disorder or depression according DSM V criteria |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- diagnosis of schizophrenia, bipolar disorder or depression according DSM V
- criteria
- age over 18 years
- informed consent to participate
- French as the native language
Key exclusion criteria (2 listed)
- diagnosis other than schizophrenia, bipolar disorder or depression according DSM V criteria
- decompensated organic disease, and mental retardation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| to develop and validate a Computerized Adaptative Testing* Elaboration of a pool of items, based on literature review and interview with patients. * Selection of the most relevant items based on a qualitative approach using cognitive interview with patients. * Calibration of the item bank : the psychometric properties of the item bank will be based on classical test and item response theories and approaches, including the evaluation of unidimensionality, item response theory model fitting, and analyses of differential item functioning. * Metrological validation of the CAT. * Analysis of the implementation of the CAT in clinical practice using interview with professionals and patients. | Other | psychiatric patients |
Primary outcome
Quality of care
Time frame: 19 months
computerized Adaptative Testing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- Derived from this study: PubMed 38753416Fernandes S, Brousse Y, Zendjidjian X, Cano D, Riedberger J, Llorca PM, Samalin L, Dassa D, Trichard C, Laprevote V, Sauvaget A, Abbar M, Misdrahi D, Berna F, Lancon C, Coulon N, El-Hage W, Rozier PE, Benoit M, Giordana B, Caqueo-Urizar A, Yon DK, Tran B, Auquier P, Fond G, Boyer L. Psychometric Assessment of an Item Bank for Adaptive Testing on Patient-Reported Experience of Care Environment for Severe Mental Illness: Validation Study. JMIR Ment Health. 2024 May 16;11:e49916. doi: 10.2196/49916.
- Derived from this study: PubMed 37677894Boyer L, Fernandes S, Brousse Y, Zendjidjian X, Cano D, Riedberger J, Llorca PM, Samalin L, Dassa D, Trichard C, Laprevote V, Sauvaget A, Abbar M, Misdrahi D, Berna F, Lancon C, Coulon N, El-Hage W, Rozier PE, Benoit M, Giordana B, Caqueo-Urizar A, Yon DK, Tran B, Auquier P, Fond G. Development of the PREMIUM computerized adaptive testing for measuring the access and care coordination for patients with severe mental illness. Psychiatry Res. 2023 Oct;328:115444. doi: 10.1016/j.psychres.2023.115444. Epub 2023 Sep 1.
- Derived from this study: PubMed 33680364Fernandes S, Fond G, Zendjidjian X, Michel P, Lancon C, Berna F, Schurhoff F, Aouizerate B, Henry C, Etain B, Samalin L, Leboyer M, Misdrahi D, Llorca PM, Coldefy M, Auquier P, Baumstarck K, Boyer L. A conceptual framework to develop a patient-reported experience measure of the quality of mental health care: a qualitative study of the PREMIUM project in France. J Mark Access Health Policy. 2021 Feb 23;9(1):1885789. doi: 10.1080/20016689.2021.1885789.
- Derived from this study: PubMed 33192054Fernandes S, Fond G, Zendjidjian XY, Baumstarck K, Lancon C, Berna F, Schurhoff F, Aouizerate B, Henry C, Etain B, Samalin L, Leboyer M, Llorca PM, Coldefy M, Auquier P, Boyer L; French PREMIUM Group. Measuring the Patient Experience of Mental Health Care: A Systematic and Critical Review of Patient-Reported Experience Measures. Patient Prefer Adherence. 2020 Nov 3;14:2147-2161. doi: 10.2147/PPA.S255264. eCollection 2020.
- Derived from this study: PubMed 30718945Fernandes S, Fond G, Zendjidjian X, Michel P, Baumstarck K, Lancon C, Berna F, Schurhoff F, Aouizerate B, Henry C, Etain B, Samalin L, Leboyer M, Llorca PM, Coldefy M, Auquier P, Boyer L. The Patient-Reported Experience Measure for Improving qUality of care in Mental health (PREMIUM) project in France: study protocol for the development and implementation strategy. Patient Prefer Adherence. 2019 Jan 21;13:165-177. doi: 10.2147/PPA.S172100. eCollection 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urielle DESALBRES study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing to develop and validate a Computerized Adaptative Testing in people with Mental Disorders, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurent BOYER (04 91 38 75 83, laurent.boyer@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of care (time frame: 19 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02491866, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2017.